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Drugs

First-Time Generic Drug Approvals - November 2011

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1TIAGABINE HYDROCHLORIDE TALBETS, 2 MG AND 4 MG      SUN PHARMACEUTICAL INDUSTRIES, LTD.GABITRIL TABLETS11/4/2011 
2LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION, 0.5 MG/ML       SYNTHON PHARMACEUTICALS, INC.XYZAL ORAL SOLUTION, 0.5 MG/ML11/7/2011 
3MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, USP 20 MG, 30 MG, 50 MG, 60 MG, 80 MG AND 100 MG  WATSON LABORATORIES, INC.KADIAN CAPSULES11/10/2011 
4EPROSARTAN MESYLATE TABLETS, 400 MG (BASE) AND 600 MG (BASE)      MYLAN PHARMACEUTICALS, INC.TEVETEN TABLETS11/16/2011 
5IMIPENEM AND CILASTATIN FOR INJECTION USP, (I.V.) 250 MG/250 MG (BASE) AND 500 MG/500 MG (BASE)      HOSPIRA INC.PRIMAXIN FOR INJECTION (I.V.)11/16/2011 
6IMIPENEM AND CILASTATIN FOR INJECTION USP, (I.V.) 500 MG/500 MG (BASE), PACKAGED IN SINGLE-DOSE INFUSION BOTTLES     HOSPIRA INC.PRIMAXIN FOR INJECTION I.V.11/16/2011 
7LAMIVUDINE TABLETS, 150 MG AND 300 MG      AUROBINDO PHARMA USA, INC.EPIVIR TABLETS11/17/2011 
8PHENYLBUTYRATE TABLETS, 500 MG       AMPLOGEN PHARMACEUTICALS, LLCBUPHENYL TABLETS11/18/2011 
9CARBOPLATIN INJECTION, 10 MG/ML; PACKAGED IN 1,000 MG/100 ML PHARMACY BULK PACKAGES     ONCO THERAPIES LIMITEDPARAPLATIN INJECTION11/23/2011 
10GUAIFENESIN EXTENDED-RELEASE TABLETS, (OTC) 600 MG       PERRIGO R&D COMPANYMUCINEX EXTENDED-RELEASE TABLETS11/23/2011 
11ENOXAPARIN SODIUM INJECTION USP, 100 MG/ML; PACKAGED IN 300 MG/3 ML MULTIPLE-DOSE VIALS (WITH PRESERVATIVE)    SANDOZ INC.LOVENOX INJECTION11/28/2011 
12ATORVASTATIN CALCIUM TABLETS, 10 MG (BASE), 20 MG (BASE), 40 MG (BASE) AND 80 MG (BASE)    RANBAXY LABORATORIES LIMITEDLIPITOR TABLETS11/30/2011 

 

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